Selective ERBB2 inhibitor CGT4255 for adults with ERBB2-altered advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label phase 1/1b trial enrolls adults with locally advanced or metastatic solid tumors harboring ERBB2 alterations, ERBB2 mutations, HER2 overexpression, or NRG1 fusions and includes breast cancer and non–small cell lung cancer cohorts. It uses a dose-escalation then expansion design to define safety, tolerability, and pharmacokinetics, with pharmacodynamic measures and preliminary antitumor activity (RECIST v1.1) as secondary endpoints. Different protocol parts target specific alteration types and tumor groups, and eligibility requires measurable disease plus defined ECOG performance status and laboratory parameters. The study will identify a recommended phase 2 dose and characterize activity in selected molecularly defined subgroups.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Have histologically confirmed diagnosis of:

   1. Part A: Locally advanced, metastatic, and/or unresectable solid tumor with documented ERBB2-activating alteration or NRG1 gene fusion in blood and/or tumor or HER2 overexpression in tumor
   2. Part B: Locally advanced, metastatic, and/or unresectable NSCLC with documented ERBB2 mutation in blood and/or tumor
   3. Part C: Locally advanced, metastatic and/or unresectable breast cancer with documented ERBB2 mutation in blood and/or tumor or HER overexpression in tumor
2. Have measurable disease per RECIST v1.1.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1 for Part A. For Parts B and C, ECOG Performance Status must be 0 to 2.
4. Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits.

Exclusion Criteria:

1. Received small molecule chemotherapy or anticancer therapies or radiotherapy within certain timeframes before first dose of study drug.
2. Major surgeries (eg, craniotomy and thoracotomy) within 4 weeks of the first dose of study drug.
3. Treatment with palliative focal radiotherapy (cranial or extracranial) (eg, stereotactic radiosurgery or intensity-modulated radiation therapy) ≤2 weeks before the first dose of study drug; treatment with whole-brain radiotherapy ≤4 weeks before the first dose of study drug.
4. Clinically significant cardiac disease.
5. Resolution of toxicities from prior therapy to ≤Grade 1 (or baseline), including resolution of clinically significant laboratory abnormalities, before the first dose of study drug.
6. Restrictions on use of corticosteroid use to manage neurologic symptoms in different parts of the study.

Where it's running

• HonorHealth Research Institute
  Scottsdale, Arizona, United States Recruiting
• Mayo Scottsdale
  Scottsdale, Arizona, United States Recruiting
• Yale Cancer Center
  New Haven, Connecticut, United States Recruiting
• Mayo Jacksonville
  Jacksonville, Florida, United States Recruiting
• Northwestern University
  Chicago, Illinois, United States Recruiting
• LSU Health Sciences Center School of Medicine
  New Orleans, Louisiana, United States Recruiting

Study contacts

• Study coordinator: Cogent Biosciences, Inc
• Email: trialinfo@cogentbio.com
• Phone: 617-945-5576

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.